Product Details

RENFLEXIS PR 100MG SDV

Manufacturer: --

MFG#: 78206-0162-01

NDC: 78206-0162-01

PID: 640925

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Additional Information

Product NameRenflexis® (Infliximab-Abda) 100 mg Injection Single-Dose Vial
ApplicationTumor Necrosis Factor (TNF) Blocker
Generic Drug NameInfliximab-abda
Mechanism of ActionBinds to TNF-a, neutralizing its inflammatory effects
Strength100 mg
TypeIntravenous (IV) Infusion
Infusion TimeAdministered over at least 2 hours under medical supervision
PrecautionsMonitor for infections, infusion reactions, and immune suppression
Adverse EffectsInfusion reactions, increased infection risk, liver enzyme elevations, reactivation of latent TB
Container TypeSingle-Dose Vial
Storage RequirementsRequires Refrigeration (2°C to 8°C / 36°F to 46°F)
Common UsesRheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis

Description

Renflexis® (Infliximab-Abda) 100 mg Injection is a biosimilar monoclonal antibody used for the treatment of autoimmune diseases. It contains 100 mg of lyophilized infliximab-abda in a 20 mL single-dose vial for intravenous infusion. The formulation targets tumor necrosis factor-alpha (TNF-a), a pro-inflammatory cytokine involved in chronic inflammatory conditions. By inhibiting TNF-a, the drug reduces inflammation and prevents disease progression in conditions such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

The mechanism of action involves binding to TNF-a, neutralizing its activity, and preventing interaction with TNF receptors on cell surfaces. This inhibition reduces inflammation, decreases immune system overactivity, and mitigates symptoms associated with autoimmune disorders. The biosimilar nature of Renflexis® ensures comparable efficacy, safety, and immunogenicity to the reference biologic infliximab.

Renflexis® is prescribed for patients who require long-term TNF inhibition to manage inflammatory diseases. Dosing schedules vary based on the condition being treated, typically involving an initial induction phase followed by maintenance doses. Patients receiving this therapy must be monitored for infusion reactions, infections, and immune-related adverse effects.

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RENFLEXIS PR 100MG SDV is manufactured by --.

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